Humeral Compression/Distraction Device

NCT ID: NCT02861495

Last Updated: 2018-09-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-08-15

Brief Summary

The proposed study of humeral shaft fractures in adults will examine outcomes in patients treated with the Humeral Trauma Nail System to treat displaced humeral shaft fractures (displaced OTA code 12A, B, or C), nonunions, or malunions. The device to be studied uses an internal gear system controlled wirelessly by rare earth magnets, which typically offers distraction for lengthening. In the humerus however, during the treatment of acute fractures, this percutaneously inserted nail can also offer compression during the healing process, thereby negating the effect of gravity, which may in turn lead to a faster and more consistent rate of union. Furthermore, in cases of slower healing the dynamic properties of the nail may employ an "accordion technique" (alternating compression-distraction, a feature unique to this implant.

Detailed Description

The primary end point will be the union rate without secondary procedures. The hypothesis is that with the compression and distraction that this device makes possible, the investigators can achieve a higher union rate than with other forms of treatment, using a percutaneous approach, with a decreased complication rate, and can dynamically modulate the healing response when needed. The primary safety endpoint is the occurrence of adverse events from the time of treatment.

During the healing process an external remote controller (ERC) will be used to continually compress or distract the fracture as needed. The surgeon will monitor healing and decide, clinically based on sequential radiographs during subsequent office visits, whether the fracture needs additional compression or distraction, an accordion technique, or no additional external manipulation via the ERC. Participants will be followed for 12 months.

Conditions

Humeral Fractures

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

humeral nail

Surgical fixation with a humeral compression/distraction nail.

Group Type: EXPERIMENTAL

Humeral Compression/Distraction (CD) Nail

Intervention Type: DEVICE

Surgical fixation of humeral shaft fractures with Humeral Compression/Distraction (CD) Nail implant

Interventions

Humeral Compression/Distraction (CD) Nail

Surgical fixation of humeral shaft fractures with Humeral Compression/Distraction (CD) Nail implant

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult skeletally mature patients 18 years or older, treated by the Orthopaedic Trauma Service at Tampa General Hospital, and the Trauma Service at St. Louis University Hospital

• Open or closed displaced humeral shaft fractures (displaced OTA code 12A, B, or C), nonunions or malunions
• amenable to treatment with an intramedullary nail

Exclusion Criteria

• Intra-articular extension of the fracture, prohibiting treatment with an intramedullary nail;
• Pathologic fracture
• Retained hardware
• Patients with pacemakers
• Age under 18 years.
• Patients who are prisoners or likely to become prisoners
• Homeless, or those likely to have difficulty making follow-up appointments
• Pregnancy
• Ipsilateral nerve or vascular injuries
• Immunocompromised patients

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NuVasive

INDUSTRY

Sponsor Role: collaborator

St. Louis University

OTHER

Sponsor Role: collaborator

Florida Orthopaedic Institute

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roy W Sanders, MD

Role: PRINCIPAL_INVESTIGATOR

Florida Orthopaedic Institute

Locations

Tampa General Hospital

Tampa, Florida, United States

Countries

United States

Other Identifiers

2001

Identifier Type: -

Identifier Source: org_study_id